Brentuximab vedotin significantly improves progression free survival in hard-to-treat Hodgkin lymphoma
by Bruce Sylvester: Researchers from a phase 3, randomized trial of brentuximab vedotin report that adults with hard-to-treat Hodgkin lymphoma treated with brentuximab vedotin immediately after stem cell transplant have achieved significantly higher survival without disease progression compared to placebo-treated subjects.
Brentuximab vedotin attaches to the CD30 protein to deliver chemotherapy directly to the cancer cell, and killing it. The drug has recently been approved for relapsed or refractory Hodgkin lymphoma in 50 countries. The findings were published on March 19, 2015 in The Lancet.
“No medication available today has had such dramatic results in patients with hard-to-treat Hodgkin lymphoma”, said lead author Craig Moskowitz, MD, Professor of Medicine at Memorial Sloan Kettering Cancer Center in New York City. “The bottom line is that BV is a very effective drug in poor risk Hodgkin lymphoma and it spares patients from the harmful effects of further traditional chemotherapy by breaking down inside the cell resulting in less toxicity,” he added.
In the AETHERA phase 3 trial, Moskowitz and colleagues investigated whether early treatment with BV after stem cell transplant could prevent disease progression.
They randomized 329 subjects aged 18 or older with Hodgkin lymphoma, and at high risk of relapse or progression after stem cell transplant, to 16 cycles of brentuximab vedotin infusions once every 3 weeks or placebo.
At 2 years, the cancer had not progressed in 65% of brentuximab vedotin subjects compared to 45% in the placebo group. “Nearly all of these patients who are progression free at 2 years are likely to be cured since relapse 2 years after a transplant is unlikely”, said Moskowitz.
Brentuximab vedotin was generally well tolerated. Side effects included peripheral neuropathy (67% brentuximab vedotin vs 13% placebo) and neutropenia (35% vs 12%).
Writing in a linked Comment, Professor Andreas Engert from the University Hospital of Cologne in Germany said, “AETHERA is a positive study establishing a promising new treatment approach for patients with Hodgkin’s lymphoma at high risk for relapse. However, with a progression-free survival of about 50% at 24 months in the placebo group, whether this patient population is indeed high risk could be debated…An international consortium is currently reassessing the effect of risk factors in patients with relapsed Hodgkin’s lymphoma to define a high-risk patient population in need of consolidation treatment. We look forward to a better definition of patients with relapsed Hodgkin’s lymphoma who should receive consolidation treatment with brentuximab vedotin.”